Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult (75 mg, 150 mg) and Pediatric (75 mg) Cystic Fibrosis Patients
1 other identifier
interventional
420
1 country
35
Brief Summary
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 13, 2003
CompletedFirst Posted
Study publicly available on registry
May 14, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedOctober 31, 2013
October 1, 2013
1.2 years
May 13, 2003
October 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted)
28 weeks
Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al
28 weeks
Secondary Outcomes (32)
Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted
28 weeks
Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted
28 weeks
Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted
28 weeks
Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted
28 weeks
Change from baseline in post-bronchodilator inspiratory capacity (IC)
28 weeks
- +27 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients \>= 6 years pediatric 6-17 years inclusive; adult \>= 18 years)
- Body weight \>= 20 kg (determined at Visit 1)
- Confirmed diagnosis of CF
- Able to perform acceptable spirometric maneuvers, according to American Thoracic Society standards .
- FEV1 25-85% predicted
- Clinically stable
- The patient or the patient's legally acceptable representative must be able to give informed consent.
- The patient must be able to swallow the BIIL 284 BS tablets whole.
- Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study.
You may not qualify if:
- Patients with a significant history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of BIIL 284 BS in allergic patients per se.
- Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit.
- Patients with known relevant substance abuse, including alcohol or drug abuse.
- Female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all females of child bearing potential).
- Female patients of child bearing potential who are not using a medically approved form of contraception.
- Patients who are unable to comply with food requirements prior to dosing.
- Patients with documented persistent colonization with Burkholderia cepacia.
- Patients chronically using oral corticosteroids or high-dose ibuprofen.
- Patients with hemoglobin \< 9.0 g/dL; platelets \< 100x10 to the 9th power/L; SGOT (ALT) or SGPT (AST) \> 2.5 times the upper limit of normal; creatinine \> 1.5 times upper limit normal.
- Clinically significant disease or medical condition other than Cystic Fibrosis or Cystic Fibrosis-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
University of Arizona
Tucson, Arizona, 85724-5073, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Stanford University Medical Center
Palo Alto, California, 94304-5786, United States
Children's Hospital & Health Center
San Diego, California, 92128-4284, United States
University of California at San Francisco
San Francisco, California, 94143-0106, United States
University of Colorado
Denver, Colorado, 80262, United States
The Nemours Children's Clinic
Orlando, Florida, 32801, United States
Pediatric Pulmonary Associates, PA
St. Petersburg, Florida, 33701, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Loyola University Medical Center
Maywood, Illinois, 60153-3333, United States
Riley Hospital
Indianapolis, Indiana, 46202-5225, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536-0284, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-0212, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University-St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198-5190, United States
Albany Medical College
Albany, New York, 12208, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7220, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308-1062, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
Columbus Children's Hospital
Columbus, Ohio, 45205, United States
MCP Hospital
Philadelphia, Pennsylvania, 19129, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232-2586, United States
Children's Memorial Center of Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Wisconsin Hospitals & Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2003
First Posted
May 14, 2003
Study Start
May 1, 2003
Primary Completion
July 1, 2004
Last Updated
October 31, 2013
Record last verified: 2013-10